ASCENSION ORTHOPEDICS MCP
FDA premarket approval P000057/S004 · decided 2008-04-24
Approval details
- PMA number
- P000057
- Supplement
- S004
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ASCENSION ORTHOPEDICS MCP
- Generic name
- Finger semi-constrained pyrolytic carbon uncemented prosthesis
- Applicant
- Smith & Nephew, Inc.
- Date received
- 2008-02-19
- Decision date
- 2008-04-24
- Days to decision
- 65 days
- Decision code
- APPR
- Product code
- NEG
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Cordova, TN
- Statement
- APPROVAL TO ADD A HYDROXYAPATITE (HA) COATING TO TE STEM OF THE ASCENSION MCP PROXIMAL AND DISTAL COMPONENTS.
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